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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K090586
Device Name BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC)
Applicant
Bovie Medical
5115 Ulmerton Rd.
Clearwater,  FL  33760
Applicant Contact RICHARD A KOZLOFF
Correspondent
Bovie Medical
5115 Ulmerton Rd.
Clearwater,  FL  33760
Correspondent Contact RICHARD A KOZLOFF
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/04/2009
Decision Date 08/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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